Validation Engineer

Description

Job Summary: Coordinate qualification and validation activities for manufacturing processes, equipment cleaning, and water systems, ensuring compliance with GMP and regulatory expectations. Key Highlights: 1. Technical execution and coordination of process qualification and validation. 2. Ensures compliance with Good Manufacturing Practices (GMP) and regulations. 3. Maintains the validated status of processes, equipment, and systems. **Job Objective** To technically execute and coordinate **qualification and validation** activities for manufacturing processes, equipment cleaning, and water systems, ensuring compliance with **Good Manufacturing Practice (GMP)** requirements, regulatory expectations (FDA, COFEPRIS, EMA), and the organization’s Quality Management System. Essential Requirements: * Engineering or related bachelor’s degree (Pharmaceutical, Chemical, Industrial, Biotechnology, or similar). * Experience in **process, cleaning, and system qualification/validation** within regulated industries. * Solid knowledge of **GMP** and regulatory frameworks (**FDA, COFEPRIS, and EMA**). * Ability to perform technical documentation and interdisciplinary collaboration. * **Technical-operational** profile, execution-oriented, organized, and possessing effective communication skills. **Key Responsibilities** * Develop and **execute qualification and validation protocols** for: * Manufacturing processes * Equipment cleaning validation * Water systems (potable water, purified water, WFI, as applicable) * Prepare **qualification and validation reports**, including data analysis, evaluation of results, deviations, and technical conclusions in accordance with GMP principles. * Verify compliance with **validation prerequisites** (equipment status, calibrations, SOPs, utilities, personnel training) prior to protocol execution. * Collect, review, and retain **objective evidence** generated during validation activities, ensuring traceability, data integrity, and documentary compliance. * Monitor and ensure **maintenance of the validated status** of processes, equipment, and systems included in the **Master Validation Plan (MVP)**. * Coordinate and monitor validation activities technically in collaboration with involved departments (Production, Quality, Engineering, Maintenance). * Coordinate and technically supervise **external vendors** performing qualification or validation activities, ensuring compliance with regulatory and quality requirements. * Monitor the **Calibration Program** executed by the Maintenance department, verifying that calibration status supports validation activities. * Actively participate in the **Validation Committee**, providing technical input for risk assessment and decision-making. * Collaborate in developing, reviewing, and maintaining the **Master Validation Plan (MVP)**. * Develop, review, and keep updated **procedures, work instructions, and forms** related to validation activities. * Maintain continuous communication with involved departments to identify validation needs, changes, and potential impacts on validated status. Salary: $25,000.00 \- $27,000.00 per month Benefits: * Medical expense insurance * Life insurance * Cafeteria service * Grocery vouchers Work Location: On-site employment